NCT04862351

Brief Summary

During this ongoing pandemic, there is a crucial need for innovative approaches to deliver CR programmes other than frequent face-to-face sessions at the centre-based CR to reduce the number of times people come close in contact with others or gathering in large groups. This is a single setting, 2-arm parallel randomised clinical trial which aims to examine the effects of technology-assisted interventions in hybrid cardiac rehabilitation (TecHCR) among the coronary heart disease patients. Eligible participants will be randomly assigned into either intervention group (IG) or control group (CG) in 1:1 ratio using the computerised permuted blocks, alternating block sizes of 4 or 6. All participants will be followed up for three months and six months with data collection at baseline, (T0), three-month (T1) and six-month (T2) time points.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

April 7, 2021

Last Update Submit

April 16, 2024

Conditions

Coronary Heart Disease

Keywords

technology-assisted interventionshybrid cardiac rehabilitationcoronary heart disease

Outcome Measures

Primary Outcomes (3)

  • self-efficacy related to exercise (Bandura's Exercise Self-efficacy)

    Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise before intervention (baseline)

    Baseline (T0) - at 0 week, before initiation of interventions

  • self-efficacy related to exercise (Bandura's Exercise Self-efficacy)

    Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise post intervention (at 3-month)

    post intervention (T1) - at 12 weeks after initiation of interventions

  • self-efficacy related to exercise (Bandura's Exercise Self-efficacy)

    Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise 3-month post intervention (T2) (at 6 month)

    6-month post intervention (T2) - at 36 weeks after initiation of interventions

Secondary Outcomes (18)

  • behavioural outcomes (Health-promoting Lifestyle Profile II)

    Baseline (T0) - at 0 week, before initiation of interventions

  • behavioural outcomes (Health-promoting Lifestyle Profile II)

    post intervention (T1) - at 12 weeks after initiation of interventions

  • behavioural outcomes (Health-promoting Lifestyle Profile II)

    6-month post intervention (T2) - at 36 weeks after initiation of interventions

  • psychological outcomes (Hospital Anxiety and Depression Scale)

    Baseline (T0) - at 0 week, before initiation of interventions

  • psychological outcomes (Hospital Anxiety and Depression Scale)

    post intervention (T1) - at 12 weeks after initiation of interventions

  • +13 more secondary outcomes

Study Arms (2)

TecHCR

EXPERIMENTAL

12 weeks Hybrid between supervised exercise training and video call sessions Educational videos Dietary and exercise log

Behavioral: exercise training for TechCRBehavioral: audio/video conferenceBehavioral: educational videoBehavioral: Daily log

Centre-based

OTHER

12 weeks usual care provided by the centre-based, outpatient cardiac rehabilitation clinic Dietary and exercise log

Behavioral: Daily logBehavioral: exercise training for centre-based

Interventions

exercise training for TechCRBEHAVIORAL

3 times of supervised exercise training at the centre-based, outpatient cardiac rehabilitation clinic

TecHCR
audio/video conferenceBEHAVIORAL

weekly audio/video conference

TecHCR
educational videoBEHAVIORAL

weekly for 6 weeks, duration of video about 10-15 minutes

TecHCR
Daily logBEHAVIORAL

daily dietary and exercise log

Centre-basedTecHCR
exercise training for centre-basedBEHAVIORAL

6 times of supervised exercise training

Centre-based

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults ≥ 18 years old;
  • patients with documented acute myocardial infarction, treated with thrombolysis, angioplasty or revascularisation surgery;
  • patients who own a mobile phone with internet access;
  • patients who have at least completion of primary school education;
  • understand English or Malay language;
  • patients who will return home for living after hospital discharge;
  • patients who are medically stable and referred to CR programme and able to give informed consent to participate in this study.

You may not qualify if:

  • patients who are participating in other studies;
  • patients who will undergo any repeat cardiac or other procedure in next 12 months;
  • patients with comorbidities such as dementia, impaired hearing or vision or psychiatric illness which may affect the ability to participate in the CR programme;
  • patients with pre-existing mobility problems which prevent them from exercising

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Location

Related Publications (2)

  • Chong MS, Sit JWH, Choi KC, Suhaimi A, Jiang Y, Chair SY. The Effects of a Technology-Assisted Hybrid Cardiac Rehabilitation (TecHCR) Program for Adults With Coronary Heart Disease: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2025 Dec;22(6):e70092. doi: 10.1111/wvn.70092.

    PMID: 41457512DERIVED

  • Chong MS, Sit JWH, Choi KC, Suhaimi A, Chair SY. A Theory-Based, Technology-Assisted Intervention in a Hybrid Cardiac Rehabilitation Program for Patients with Coronary Heart Disease: A Feasibility Study. Asian Nurs Res (Korean Soc Nurs Sci). 2023 Aug;17(3):180-190. doi: 10.1016/j.anr.2023.06.004. Epub 2023 Jun 22.

    PMID: 37355035DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mei Sin Chong

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A single blinding will be implemented for the outcome assessor as the participants will not be able to be blinded due to the nature of the interventions. The participants will not be informed directly whether they are in the intervention group or control group but the information regarding the intervention will be stated in the Participant Information Sheet. Thus, the participants may know their group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The eligible participants will be randomly assigned into either intervention group (IG) or control group (CG) in 1:1 ratio using the computerised permuted blocks, alternating block sizes of 4 or 6. Once the eligible participants have consented to participate and the baseline data is collected, they will be given an opaque sealed envelope prepared by an independent statistician (not involved in the research) with assignment information and group allocation specified in the envelope. According to Polit and Beck (2017), the risk of selection bias can be reduced through allocation concealment by shielding the researcher from knowing the next group allocation of an individual.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 28, 2021

Study Start

February 26, 2021

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)